Senior Medical Writer

Placements24; Noord-Kaap; Presencial; ZAR 900.000 - 1.300.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Provident fund

Annual bonus

Generous annual leave

Descripción de la vacante

Placements24's client, a respected pharmaceutical company, seeks a Senior Medical Writer to join their documentation team in Kimberley, Northern Cape. You will author, edit and review regulatory and scientific documents, contribute to submissions, and ensure accuracy and regulatory compliance.

The role requires 5–7 years in medical writing, a scientific degree (PhD a plus), strong writing skills and ability to manage multiple projects, mentor junior writers, and collaborate with clinical

Formación

• Bachelor's or Master's degree in a scientific, medical, or related field.
• A Ph.D. is a plus.
• Minimum of 5–7 years of experience as a Medical Writer in pharma/biotech.
• Experience authoring regulatory/clinical documents (protocols, CSRs, IBs).
• Understanding of drug development, ICH guidelines.
• Strong writing, editing, proofreading skills.

Responsabilidades

• Author, edit, and review regulatory and scientific documents (protocols, CSRs, IBs).
• Prepare submissions-ready documents for health authorities.
• Ensure documents meet scientific, medical, regulatory standards.
• Collaborate with cross-functional teams (clinical ops, biostatistics, regulatory affairs).
• Manage document timelines and deliver high-quality outputs.
• Stay current on therapeutic areas and regulatory guidelines.
• Contribute to documentation standards and templates.
• Perform literature searches to support documents.
• Provide mentorship to junior writers and review others' work.

Conocimientos

Regulatory writing

Editing

Attention to detail

Communication

Time management

Educación

Bachelor's or Master's degree in science/medicine

PhD is a plus

Herramientas

Literature databases

Information retrieval

Descripción del empleo

About the Role

Our client, a highly respected pharmaceutical company dedicated to advancing global health, is seeking a Senior Medical Writer to join their talented documentation team in Kimberley, Northern Cape . This role is paramount in ensuring clear, accurate, and compliant communication of scientific and clinical data. The Senior Medical Writer will be responsible for authoring a wide range of regulatory and scientific documents essential for drug development and approval processes. This position requires a meticulous approach, a strong grasp of scientific principles, and the ability to translate complex data into accessible narratives. The successful candidate will play a key role in supporting regulatory submissions and disseminating critical information to various stakeholders. We are looking for an experienced writer with a proven ability to manage multiple projects and deadlines effectively.

Key Responsibilities

• Author, edit, and review various regulatory and scientific documents, including clinical study protocols, clinical study reports (CSRs), investigator's brochures (IBs), and briefing documents.
• Prepare submissions-ready documents for health authorities worldwide (e.g., SAHPRA, FDA, EMA).
• Ensure all documents meet required scientific, medical, and regulatory standards for accuracy, clarity, and completeness.
• Collaborate closely with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and project management.
• Manage document development timelines, ensuring timely delivery of high-quality outputs.
• Maintain a thorough understanding of therapeutic areas, drug development processes, and regulatory guidelines.
• Contribute to the development and implementation of company documentation standards and templates.
• Perform literature searches and synthesize information from various sources to support document creation.
• Provide guidance and mentorship to junior medical writers.
• Review and critique documents authored by others.

Requirements

• Bachelor's or Master's degree in a scientific, medical, or related field.
• A Ph.D. is a plus.
• Minimum of 5-7 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Demonstrated expertise in authoring a variety of regulatory and clinical documents (protocols, CSRs, IBs).
• Thorough understanding of drug development processes, clinical trial methodologies, and ICH guidelines.
• Excellent writing, editing, and proofreading skills with exceptional attention to detail.
• Proficiency in scientific literature databases and information retrieval.
• Strong analytical and critical thinking abilities.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Effective communication and interpersonal skills to collaborate with diverse teams.
• Familiarity with regulatory submission processes and requirements.

Benefits

Our client offers a competitive salary commensurate with experience, along with comprehensive health benefits, a provident fund, and an annual bonus. This role provides significant opportunities for professional growth and skill development within a leading pharmaceutical organization. Employees benefit from a supportive team environment and access to resources that foster continuous learning. We also provide generous annual leave and promote a healthy work-life balance. Join a company that values clear communication and scientific integrity in bringing important medicines to patients.